Ignite Creation Date:
2024-05-05 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 9:44 AM
Study NCT ID:
NCT00617617
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2008-02-05
Brief Title:
The Specific Role of Isoflavones in Reducing Prostate Cancer Risk
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
The Specific Role of Isoflavones in Reducing Prostate Cancer Risk
Status:
COMPLETED
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to determine if giving men with early stage Grade 1-2 prostate cancer dietary supplement from soybeans called isoflavones will change their blood hormone levels Isoflavones are substances found in a high concentration in soybeans that are converted in the intestines to hormone-like compounds which are similar to estrogen They are also thought to have cancer fighting properties Clinical trials suggest that isoflavones can increase certain sex hormones which results in the slower production of prostate cancer cells This study will determine if adding isoflavones supplied as Prevastein HC 80 mgday in a pill form can change your risk factors that cause early stage prostate cancer to progress to more advanced disease
Detailed Description:
To prevent biasing the outcome of the study this is a double-blind study design where both the trialists and the participants are blinded to the specific nature of the product isoflavones and placebo Participants in both groups will be discouraged from increasing their intake of dietary isoflavones in the form of tofu soy beans soy milk etc In addition the intervention does not include active counseling on dietary modification and supplementation of any one group Monthly appointments will be made for all participants for data collection and toxicity assessment
Schema
This is a controlled randomized double blinded clinical trial having one experimental and one control group n - 75arm Participants in the experimental group will consume an isoflavones supplement in the form of Prevastein HC which will deliver 80 mgs 40 mgdose biologically active isoflavones and those in the control group will receive an identical placebo The isoflavones supplement and the placebo tablets will be manufactured and packaged by Cognis Corporation
1 Isoflavones will be supplied at no charge by Cognis Corporation LaGrange Illinois as Prevastein HC Each Prevastein HC tablet delivers 20 mg biologically active isoflavones which is available for absorption Participants will consume 2 tablets twice daily with meals in addition to their usual diet
2 Placebo will be supplied at no charge by Cognis Corporation LaGrange Illinois as an indistinguishable tablet Participants will consume 2 tablets twice daily with meals in addition to their usual diet
3 A standardized multivitamin will be supplied at no charge
Schema
This is a controlled randomized double blinded clinical trial having one experimental and one control group n - 75arm Participants in the experimental group will consume an isoflavones supplement in the form of Prevastein HC which will deliver 80 mgs 40 mgdose biologically active isoflavones and those in the control group will receive an identical placebo The isoflavones supplement and the placebo tablets will be manufactured and packaged by Cognis Corporation
1 Isoflavones will be supplied at no charge by Cognis Corporation LaGrange Illinois as Prevastein HC Each Prevastein HC tablet delivers 20 mg biologically active isoflavones which is available for absorption Participants will consume 2 tablets twice daily with meals in addition to their usual diet
2 Placebo will be supplied at no charge by Cognis Corporation LaGrange Illinois as an indistinguishable tablet Participants will consume 2 tablets twice daily with meals in addition to their usual diet
3 A standardized multivitamin will be supplied at no charge
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CA 81920 | None | None | None |
| NCI 4031 | None | None | None |